Artivion, Inc: Device Recall
Recall #Z-2531-2024 · 05/28/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2531-2024
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Artivion, Inc
- Status
- Ongoing
- Date Initiated
- 05/28/2024
- Location
- Kennesaw, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 valves
Reason for Recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Product Description
CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve Allograft Prepared with SynerGraft (SG) Technology.
Distribution Pattern
US Nationwide distribution in the states of CA, DC, FL, and NY.
Other Recalls by Artivion, Inc
- Class II: Risk 05/28/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.